Left Ventricular Thrombus Formation After Acute Myocardial Infarction - a Randomized Multi-center Trial Comparing Two Different Anti-thrombotic Regimens
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
研究概览
简要总结
Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST segment elevation myocardial infarction (STEMI). It is a feared complication since it might increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K antagonist treatment in these patients. However patients with STEMI nowadays undergo primary percutaneous coronary intervention (PCI) with coronary stent placement and consequently require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis. Consequently, STEMI patients with LV thrombus are currently treated with triple antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral. The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to address this issue.
Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of the study is to determine in a randomized fashion the risks and benefits of the addition of vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline Magnetic Resonance Imaging (MRI).
详细描述
Design: A multicenter, prospective, randomized, non-inferiority trial with blinded evaluation of endpoints
Objective: The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation
Patients: Patients with acute myocardial infarction treated with primary PCI and LV thrombus on baseline echocardiography or baseline Magnetic Resonance Imaging. (MRI)
Methods: After written informed consent has been obtained, echocardiography and MRI are performed between 7-12 days after PCI. When LV thrombus is present on baseline MRI, patients are randomized to
- Triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet agent,) and vitamin K antagonist (goal INR is 2.0 to 3.0))
- Dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected Left Ventricular thrombus on echocardiography or routine Magnetic Resonance Imaging
- •Ongoing treatment with dual antiplatelet therapy according to ESC/ACC-AHA guidelines at the time of randomization.
排除标准
- •Younger than 18
- •Clinically or hemodynamically unstable
- •Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months
- •Previous stroke or transient ischemic attack
- •Scheduled for major surgery (including Coronary Artery Bypass Grafting) during the course of the study
- •Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists
- •Contra-indication for vitamin K antagonist treatment
- •Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study
- •Congenital cardiac disease
- •Presence of supraventricular or ventricular arrhythmias
- •Expected candidate for ICD implantation with the next 6 months
- •Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation 5 30mL/min)
- •Known or symptomatic brain disease (such as brain tumor)
- •Women who are pregnant.
- •Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging (such as pacemaker, cerebrovascular clips, known contrast allergy, claustrophobia)
- •Follow-up impossible (for example no fixed abode)
研究组 & 干预措施
vitamin K antagonist -
Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day)
干预措施: Absence of vitamin K antagonist (Drug)
结局指标
主要结局
The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
时间窗: 6 months relative to baseline
Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by Magnetic Resonance Imaging.
次要结局
- The presence of new cerebral micro-bleeds assessed by MRI(At 6 months and 12 months relative to baseline)
- Occurrence of major and minor bleeding(At 6 and 12 months relative to baseline)
- Quality of life using a validated checklist(At 6 and 12 months relative to baseline)
- Neurological status(At 6 and 12 months relative to baseline)
- Composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism(At 6 and 12 months relative to baseline)
研究者
Jan Piek
Clinical Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)